MUCUS RELIEF - guaifenesin tablet, extended release 
Aphena Pharma Solutions - Tennessee, LLC

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MUCUS RELIEF
Guaifenesin Extended-Release Tablets 600 mg

ACTIVE INGREDIENT(in each extended-release tablet)

Guaifenesin 600 mg

PURPOSE

Expectorant

USE(S)

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNING

.

DO NOT USE

for children under 12 years of age

ASK A DOCTOR BEFORE USE IF YOU HAVE

STOP USE AND ASK A DOCTOR IF

IF PREGNANT OR BREAST-FEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

1-800-616-2471

You may also report side effects to this phone number. 

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count600 mg
1271610-499-12
6071610-499-53

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20201217JH

PRINCIPAL DISPLAY PANEL - 600 mg

NDC 71610-499 - Guaifenesin ER 600 mg Tablets
Bottle Label 600 mg

MUCUS RELIEF 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-499(NDC:0904-6986)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code G233
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-499-1212 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2021
2NDC:71610-499-5360 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20921509/23/2019
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-499)

Revised: 5/2021
Document Id: 349de2f9-ec60-43d7-990a-074c673aa7e3
Set id: 01af03f1-5d1b-4893-b7db-7092ba66e842
Version: 2
Effective Time: 20210503
 
Aphena Pharma Solutions - Tennessee, LLC